STUDY OF PEMBROLIZUMAB (MK-3475) COMPARED TO PLATINUM-BASED CHEMOTHERAPIES IN PARTICIPANTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (MK-3475-042/KEYNOTE-042)

Gender: Both
Maximum age: 100
Minimum age: 18
Inclusion criteria:
At least one radiographically measurable lesion per RECIST 1.1.
Be ≥18 years of age
Life expectancy of at least 3 months
Not received prior systemic chemotherapy treatment for their advanced/metastatic NSCLC
Performance status of 0 or 1 (ECOG)
Adequate organ function
No history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer
Provided formalin fixed tumor tissue from a biopsy of a tumor lesion AFTER the diagnosis of metastatic disease has been made AND from a site not previously irradiate
Histologically or cytologically confirmed diagnosis of advanced or metastatic
Have a PD-L1 positive tumor as determined by IHC
Female subjects must have a negative urine or serum pregnancy test if of childbearing potential or be of non-child bearing potential.
Heterosexually active women are willing to use two methods of birth control (which is also recommended for the female partners of male subjects). The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Subjects should start using birth control from study Visit 1 throughout the study period up to 120 days after the last dose of pembrolizumab and up to 180 days after last dose of chemotherapeutic agents or TKIs
Voluntarily agreed to participate by giving written informed consent

Exclusion criteria:
EGFR sensitizing mutation and/or is EML4/ALK fusion positive
Tumor specimen is not evaluable for PD-L1 expression
Subjects with squamous histology who received carboplatin in combination with paclitaxel
Is receiving systemic steroid therapy < 3 days prior to the first study dose
NSCLC can be treated with curative intent with either surgical resection and/or chemo-radiation
Expected to require any other form of systemic or localized antineoplastic therapy while on trial
Received any prior systemic cytotoxic chemotherapy, biological therapy major surgery within 3week of first study dose: radiation therapy of > 30 Gy within 6 months of the first dose; received palliative radiotherapy of 30Gy or less within 7 days of the first dose.
Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Known central nervous system metastases and/or carcinomatous meningitis
Had an allogeneic tissue/solid organ transplant
Active infection, or autoinmune disease
Known history of Human Immunodeficiency Virus, pneumonitis or active Hepatits B or C
Pregnant or breastfeeding, or expecting to conceive or father children